Hello, I would like to consult the medical device registration specialist this post development good, later want to start a business can do how to do, can do that kind of registration on behalf of oth

Hello, I would like to consult the medical device registration specialist this post development good, later want to start a business can do how to do, can do that kind of registration on behalf of others? Hello, the medical device registration specialist is mainly responsible for the registration process of the preparation of information and daily communication duties, report to the registration director; registration work is from the prototype ready to start (prototype + manual + safety critical parts + self-test report + commonly used registration documents), the testing process, the clinical process, the review process, to obtain the certificate of registration of the product of the whole process.

1, responsible for organizing the preparation and revision of product registration standards;

2, responsible for the registration of all types of applications in the drafting, submission and receipt of the return receipt work;

3, responsible for the registration declaration of the relevant information on the translation and proofreading;

4, responsible for the Food and Drug Administration, the Center for Technical Evaluation, the Center for the Supervision of Quality and Testing of Medical Devices

4, responsible for daily communication with the Food and Drug Administration, Technical Review Center, Medical Device Quality Supervision and Testing Center and other relevant departments, and report the situation to the registration director in a timely manner;

5, responsible for the custody of the submitted documents and information;

6, is responsible for the registration of samples under the order, the number of confirmation;

7, is responsible for the development of my registration tasks regularly to promote the plan and submit it to the director of the registration review;

8, is responsible for the registration of the prepared The registration declaration materials for the preparation and review;

9, is responsible for receiving the review of the drug regulatory authorities, and according to the views of the modification, or communication with other departments to resolve;

10, is responsible for the testing engineer's travel arrangements and reception;

11, supervise the company's testing department to test the test prototypes, standard terms of the formation of self-testing report Audit;

12, to assist testing engineers to complete the sample testing and record the relevant important data;

13, to complete the registration of other tasks arranged by the director.

14, responsible for every two months or irregularly to other departments for new standards or new regulations training.

15, to help R & D technicians to solve the active or passive items of the standard program and define the problem.

16, preliminary review of the Institute's active or passive product output information for regulatory compliance.

17, international and national medical device standards collection, archiving, etc.

18, registration testing, clinical application, contact and test report tracking, submission of registration information and certificate collection, proofreading, etc.

19, responsible for obtaining the registration certificates, including SFDA, CE, CCC, FDA.